MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. ROTOPRONE; IKZ

Model Number 209800-R

Device Problems Detachment Of Device Component (1104); Device Inoperable (1663); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for the rotoprone devices, we have not been able to find any other event with the fault descriptions compared to the situation investigated here: patient's head not secured correctly in the headrest/facepack due to use error.There is no trend observed for reportable complaints with this failure for these devices.Based on the information collected to date, provided problem description and evaluation of the device involved in the event conducted by an arjohuntleigh representative, we have been able to establish that the adjustment knob on the facepack was over-tightened - and as a result moved the adjustment nut causing it to cease up against the head gear - the knob was coming off without loosening the head gear because the nut was forced into the head gear.The technician was able to repair the device at the facility.The in-service training has been provided to the nursing staff on the proper face pack adjustments.It was also clarified that the event occurred during a routine check of the patient.There was no injury to the patient or caregivers as a result of the incident.There was no need to replace the device with a new one and the patient remained on the same bed with no further incidents.Review of the device labeling (user manual #208622-ah rev.C) which was delivered to the facility together with the device revealed that it include information how to properly remove and install the facepack and how to adjust it.Head support packs should lightly touch sides of patient's head without compressing the pack foam or puckering patient's skin.Fitting the head support, face pack or other packs too tightly may increase pressure points, possibly leading to skin breakdown.In summary, the device was being used at the time of the event, it failed to operate as intended as it suffered a malfunction due to a use error.Fortunately there were no injuries sustained.This event is reported in an abundance of caution and to be transparent.Given the circumstances and the number of similar events, this incident appears to be an isolated one.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Initially, it has been claimed by the facility's nurse that the facepack was damaged (piece broke off) and therefore further rotation of the device is not possible.Immediate help has been requested.

• Brand Name: ROTOPRONE
• Type of Device: IKZ
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJOHUNTLEIGH INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5235039
• MDR Text Key: 31571839
• Report Number: 3007420694-2015-00215
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/19/2015,10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 209800-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/19/2015
• Distributor Facility Aware Date: 10/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other